FDA 483 - Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company - September 11, 2017

An FDA inspection of Bristol-Myers Squibb Holdings Pharma Ltd in Manati, Puerto Rico, identified significant deficiencies in data integrity and laboratory controls. The firm failed to adequately monitor and investigate electronic record issues from chromatographic systems, leading to unaddressed data loss or alteration. Additionally, laboratory investigations for drug products like Coumadin and Elotuzumab Injection were found to be scientifically unsound, and the firm did not thoroughly review unexplained discrepancies related to product testing and release.